Journal of Clinical Oncology, Vol 18, Issue 14
(July), 2000: 2648-2657
© 2000 American Society for Clinical Oncology
Final Results of a Randomized Phase III Trial of Sequential High-Dose Methotrexate, Fluorouracil, and Doxorubicin Versus Etoposide, Leucovorin, and Fluorouracil Versus Infusional Fluorouracil and Cisplatin in Advanced Gastric Cancer: A Trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group
By Udo Vanhoefer,
Philippe Rougier,
Hansjochen Wilke,
Michel P. Ducreux,
Angel J. Lacave,
Eric Van Cutsem,
Manfred Planker,
José Guimaraes Dos Santos,
Pascal Piedbois,
Bernard Paillot,
Heinrich Bodenstein,
Hans-Jochen Schmoll,
Harry Bleiberg,
Bernard Nordlinger,
Marie-Laure Couvreur,
Benoit Baron,
Jacques A. Wils
From the Department of Internal Medicine (Cancer Research), West German Cancer Center, University of Essen Medical School, Essen; Klinikum Krefeld, Krefeld; Klinikum Minden, Minden; Clinic for Hematology and Oncology, Martin-Luther-University, Halle, Germany; Hôpital Ambroise Paré, Paris; Institut Gustave Roussy, Villejuif Cedex; Henri Mondor Hospital, Creteil; Centre Hospitalier Universitaire de Rouen, Rouen-Cedex, France; Servicio de Oncologia Medica, Hospital General de Asturias, Oviedo, Spain; Department of Internal Medicine, University Hospital Gasthuisberg, Leuven; Institut Jules Bordet and European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium; Instituto Portuges de Oncologia, Porto, Portugal; and St Laurentius Ziekenhuis, Roermond, the Netherlands.
Address reprint requests to U. Vanhoefer, MD, Department of Internal Medicine (Cancer Research), West German Cancer Center, University of Essen Medical School, Hufelandstr 55, 45122 Essen, Germany; email udo.vanhoefer{at}uni-essen.de .
PURPOSE: To compare the efficacy and tolerability of etoposide, leucovorin, and bolus fluorouracil (ELF) or infusional fluorouracil plus cisplatin (FUP) with that of the reference protocol of fluorouracil, doxorubicin, and methotrexate (FAMTX) in advanced gastric cancer.
PATIENTS AND METHODS: A total of 399 patients with advanced adenocarcinoma of the stomach were randomized and analyzed for toxicity, tumor response, and progression-free and overall survival. Only reviewed and confirmed responses were considered. The analysis of remission was based on assessable patients with documented measurable lesions. The intent-to-treat principle, log-rank test, and Cox regression model were used for the statistical analysis of time-to-event end points.
RESULTS: The overall response rate for 245 eligible patients with measurable disease was 9% with ELF, 20% with FUP, and 12% with FAMTX, with no significant differences. One hundred twelve patients were eligible for efficacy in assessable, nonmeasurable disease. No change was observed in 66% of patients treated with ELF, 56% with FUP, and 55% with FAMTX. Two patients achieved a complete tumor regression (one each for ELF and FAMTX). With a median follow-up time of 4.5 years, the median survival times were 7.2 months with ELF, 7.2 months with FUP, and 6.7 months with FAMTX, respectively, with no significant differences. Nonhematologic and hematologic toxicities of ELF, FUP, and FAMTX were acceptable, with neutropenia being the major toxicity for all three regimens. Seven treatment-related deaths occurred (two with FUP and five with FAMTX).
CONCLUSION: All three investigated regimens demonstrate modest clinical efficacy and should not be regarded as standard treatment for advanced gastric cancer. New strategies should be considered to achieve a better clinical efficacy in the treatment of advanced gastric cancer.
Presented in part at the Thirty-First Annual Meeting of the American Society of Clinical Oncology, Los Angeles, CA, May 20-23, 1995.
The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
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